Quality Is Non-negotiable
When it comes to the conduct of clinical trials, quality and compliance are non-negotiable requirements in every step of the process. Risks threaten the most well-planned drug development. PPD offers consulting services to support and enhance the robust clinical activity for which we are known. PPD’s global quality and compliance (GQC) services are delivered by trained professionals who have honed their expertise over decades of experience.
Comprehensive and Client-specific Expertise
PPD listens to clients’ concerns and tailors the delivery of expertise to meet their needs. Services are contracted and performed per standard operating procedures, or as defined by projects.
This can include:
- Auditing processes, clinical trial sites, labs, vendors and pharmacovigilance activities
- Auditing report design and data analysis of audit metrics
- Pre-inspecting activities, mock inspections and follow-up support
- Developing risk management frameworks to escalate quality concerns
- Implementing and managing CAPA system
- Investigating suspected scientific misconduct
- Developing standards/systems for procedural document management and control
- Developing quality agreements, conduct of quality council meetings
- Training on how to host regulatory authority inspections
- Analyzing training for standardization into core curricula
- Creating and maintaining product specification files
- Coordinating ID testing for product import into the European Union
- Assessing software vendors
- Assessing FDA 21 CFR Part 11
- Developing or maintaining retention schedules
- Due diligence processing prior to disposition of business records
- Setting up and maintaining eTMF
Project Risk Assessment Questionnaire
A key offering is the proprietary Project Risk Assessment Questionnaire (PRAQ), a risk management tool developed by PPD quality and compliance experts. The PRAQ addresses every component of clinical trial activity from pre-study start through study closeout. The PRAQ also includes a ranking of risk and identifies proactive mitigations for those risks.